Comparison of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block After Elective Cesarean Section

NCT07411521 | Recruiting

• 1 other identifier: Bursa City Hospital 005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain after cesarean section can significantly affect maternal recovery, early mobilization, and patient satisfaction. Regional anesthesia techniques are widely used to improve postoperative analgesia and reduce opioid consumption. Combined spinal-epidural analgesia is commonly used for cesarean section and provides effective pain control but may be associated with technical difficulties and potential complications. The erector spinae plane block is a newer ultrasound-guided regional anesthesia technique that has shown promising results for postoperative pain management in various surgical procedures. The aim of this study is to compare the postoperative analgesic effectiveness of combined spinal-epidural analgesia and the erector spinae plane block in patients undergoing elective cesarean section. Pain intensity will be assessed using the visual analog scale at multiple postoperative time points. Maternal recovery will be evaluated using the Obstetric Quality of Recovery-11 questionnaire. Secondary outcomes will include postoperative nausea, pruritus, time to first analgesic request, mobilization time, and patient satisfaction. This study will help determine whether the erector spinae plane block can provide comparable or improved postoperative pain control with fewer complications compared to combined spinal-epidural analgesia.

Conditions

Postoperative Pain After Cesarean Section

Keywords

Cesarean Section; Combined Spinal Epidural Analgesia; Erector Spinae Plane Block; Postoperative Pain Management; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores Assessed by Visual Analog Scale (VAS)

  Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at 0, 1, 6, 12, and 24 hours after surgery. Dynamic VAS scores will also be recorded during movement.

  0, 1, 6, 12, and 24 hours postoperatively

Secondary Outcomes (3)

• Postoperative Recovery Quality Assessed by Obstetric Quality of Recovery-11 (ObsQoR-11)

  Within the first 24 hours postoperatively

• Time to First Analgesic Requirement

  First 24 hours postoperatively

• Postoperative Adverse Effects

  Within the first 24 hours postoperatively

Study Arms (2)

Combined Spinal Epidural Analgesia Group

ACTIVE COMPARATOR

Participants receive combined spinal-epidural analgesia for cesarean section anesthesia and postoperative pain management according to institutional protocol.

Other: Combined Spinal Epidural Analgesia

Erector Spinae Plane Block Group

ACTIVE COMPARATOR

Participants receive spinal anesthesia for cesarean section followed by ultrasound-guided bilateral erector spinae plane block for postoperative analgesia.

Other: Ultrasound-Guided Erector Spinae Plane Block

Interventions

Combined Spinal Epidural Analgesia OTHER

Combined spinal-epidural analgesia is performed for cesarean section anesthesia using standard institutional technique, providing intraoperative anesthesia and postoperative pain control through epidural catheter administration.

Combined Spinal Epidural Analgesia Group

Ultrasound-Guided Erector Spinae Plane Block OTHER

Bilateral ultrasound-guided erector spinae plane block is performed following spinal anesthesia for cesarean section to provide postoperative analgesia.

Erector Spinae Plane Block Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18-45 years
• Scheduled for elective cesarean section under regional anesthesia
• American Society of Anesthesiologists (ASA) physical status I-II
• Singleton pregnancy at term gestation
• Ability to understand the study protocol and provide written informed consent

You may not qualify if:

• Refusal to participate in the study
• Contraindications to regional anesthesia (coagulopathy, infection at injection site, severe hypovolemia)
• Known allergy to local anesthetics or study medications
• Body mass index (BMI) \> 40 kg/m²
• Chronic opioid use or chronic pain disorders
• Neurological disorders affecting sensory assessment
• Severe obstetric complications (e.g., preeclampsia, placenta previa, fetal distress)

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

RECRUITING

Study Officials

• Serra Topal

  Bursa City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasemin Nur Tekin

CONTACT

+905365541611; yaseminnurguney@gmail.com

Emre ULUSOY

CONTACT

+905379492799

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Reanimation

Model Details: Participants will be assigned in parallel to one of two intervention groups: combined spinal-epidural analgesia or spinal anesthesia followed by ultrasound-guided erector spinae plane block.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 17, 2026
• Study Start: March 15, 2026
• Primary Completion: May 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)